PRAHS

  • Regulatory Affairs Coordinator (Product Registration/Post-Registration

    Job Locations - | Brazil-Sao Paolo
    Posted Date 1 week ago(8/10/2018 10:11 AM)
    ID
    2018-48586
  • Overview

    Job description:
    •Preparing the registration file according to the regulation
     (new drug application, new indication, line extension, variations, renewals, etc.),
    •Follow-up the registration steps on the process.
    •Distribute regulatory documents, publications, and other relevant materials.
    •Check information published by ANVISA and proceed with rectification request or data base correction, if needed.
    •Monitoring reporting and setting timelines for the variations, renewals, pharma vigilance related activities, databases.
    •Responsible for Management of team members and ensuring excellent team dynamic.
    •Directly responsible in regulatory activities to ensure compliance with legal provisions issued by regulatory entities and customer requirements in due time and legal form.
    •Provides regular updates to management and maintains status / metrics tracker as appropriate.
    •Regulatory Affairs team leadership.

    Responsibilities

    Job description:
    •Preparing the registration file according to the regulation
     (new drug application, new indication, line extension, variations, renewals, etc.),
    •Follow-up the registration steps on the process.
    •Distribute regulatory documents, publications, and other relevant materials.
    •Check information published by ANVISA and proceed with rectification request or data base correction, if needed.
    •Monitoring reporting and setting timelines for the variations, renewals, pharma vigilance related activities, databases.
    •Responsible for Management of team members and ensuring excellent team dynamic.
    •Directly responsible in regulatory activities to ensure compliance with legal provisions issued by regulatory entities and customer requirements in due time and legal form.
    •Provides regular updates to management and maintains status / metrics tracker as appropriate.
    •Regulatory Affairs team leadership.

    Qualifications


     Requirements:
    •Degree in life science-related discipline or professional equivalent.
    •Ability to manage multiple tasks and times (time overlapping).
    •Ability to establish and maintain effective working relationships with co-workers, managers and clients.
    •Team management.
    •Fluent English mandatory (oral and written).

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